Brief description of study

The purpose of this study is to assess the effectiveness and safety of rivaroxaban compared
with placebo (inactive medication), in reducing the risk of death, myocardial infarction or
stroke in participants with heart failure and significant coronary artery disease following
an episode of decompensated heart failure.

Detailed Study Description

This is a randomized (the study medication is assigned by chance), double-blind (neither
physician nor participant knows the identity of the assigned treatment), parallel group (each
participant group receives different treatments simultaneously), event driven (the study
duration is determined by the time taken for a specific number of events to occur),
multicenter study to assess the effectiveness and safety of rivaroxaban compared with
placebo, in reducing the risk of death, myocardial infarction or stroke in participants with
heart failure and significant coronary artery disease following an episode of decompensated
heart failure. Participants will be randomly assigned in a 1:1 ratio to receive either
rivaroxaban or placebo (each in addition to standard of care for heart failure and coronary
artery disease as prescribed by their managing physician). The study will consist of a
screening phase, a double-blind treatment phase, and a follow-up after the sponsor-announced
global treatment end date (GTED, defined as the date when 1200 primary efficacy outcome
events are predicted to have occurred). The double-blind treatment phase is estimated to last
for 6 to 54 months. Participants will discontinue study drug after taking both their morning
and evening doses on the GTED and will return to the study center for the end-of-study visit
(between 15 and 45 days but no sooner than 15 days after the GTED). Patient safety will be
monitored throughout the study. The average study duration for participants is expected to be
approximately 29 months. The study drug, rivaroxaban, is approved in the United States and in
multiple countries around the world for the prevention and treatment of a number of
thrombosis-mediated conditions.